Vascular Solutions Approved for Device Study

Minneapolis, MN-based Vascular Solutions said it has received conditional approval from the FDA to begin testing use of its Thrombin-VSI as a component in the company’s existing hemostatic devices.
    The trial will assess the performance of Thrombin-VSI in comparison to the company’s original source of thrombin in use with the Company’s Diagnostic Duett Pro sealing device, Vascular Solutions said.
    The study will also focus on qualifying Thrombin-VSI for use in the device maker’s existing line of hemostats, including D-Stat Dry, D-Stat Radial, ThrombiGel and D-Stat Flowable.
    “This conditional approval is an important milestone in the qualification of our new source of thrombin to control our long term supply and cost for our hemostatic devices,” said Vascular Solutions CEO, Howard Root.
    He said the new study would get under way in the third quarter of this year at about 10 US centers.